Medical Wire Harness
ISO/IATF certified custom wiring harnesses for medical devicesMedical wire harnesses are the backbone of medical equipment, ensuring reliable performance and connecting sensors, power systems, and data pathways. SAISONIC can produce cables and spare parts according to your schematics or material list, ranging from simple cables to complex harness assemblies. We also provide OEM/ODM wiring solutions for medical equipment.
Since obtaining the ISO 13485 certification for medical wire harnesses in 2013, SAISONIC has been supplying wire harnesses to treatment equipment (oxygen concentrators, infusion pumps), vital signs monitors, home care devices (portable patient monitors, glucose meters, hearing aids, and oxygen concentrators), and medical aesthetics equipment (beauty devices, hair removal devices, and light therapy devices).
With three decades of experience in medical wire harnesses design and manufacturing, SAISONIC recognizes that producing medical harnesses requires careful attention to both safety and compliance standards.
As public and patients safety heavily depends on medical equipment, it’s hard to underestimate the importance of medical wire harness assemblies. No doubt that even a small deviation from specifications or a non-standardized workflow can lead to device malfunction or failure. Think of the consequences of a faulty wire harness in a heart rate monitor, for instance. That’s why every medical harness should be manufactured with tight tolerances and undergo rigorous quality testing to ensure its reliability. SAISONIC implements a comprehensive quality management system to produce medical wiring harnesses distinguished by their quality and tailored to meet specifications.
To ensure safety, the medical industry sets strict standards like ISO 13485, IEC 60601-1/2, and IEC 60512 for manufactures of medical wire harness assemblies.
- ISO 13485: sets quality management requirements for designing and manufacturing medical devices, including cable assemblies. SAISONIC is certified to this standard and has been internationally recognized for industry compliance.
- ISO 10993: provides guidelines to test materials used in medical devices are safe for the body, including testing for cytotoxicity, sensitization, irritation, acute toxicity, and other risks.
- IEC 60601-1: defines safety and performance requirements for medical electrical systems, including cable assemblies. It covers general safety, electrical hazard testing, and mechanical integrity.
- IEC 60601-2: deals with electromagnetic compatibility (EMC), making sure cable assemblies don’t interfere with other devices and aren’t affected by interference.
- IEC 60512: sets the requirements to test connectors in cable assemblies for electrical reliability, mechanical function, and resistance to environmental conditions.
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Harness for Phototherapy Devices -
Wiring Harness for Beauty Devices -
Cable Harness for Hair Removal devices -
Harness for Glucometers -
Wire Harness for Electric Care Beds -
Cable Harness for Oxygen Concentrators -
Harnesses for Assistive Devices -
Wiring Harness for Rehabilitation Devices -
Harness for Height-Adjustable Toilets -
Cable Harness for Electromagnetic Therapy Devices -
Wire Harness for Massage Chairs -
Harness for Blood Pressure Monitors
SAISONIC is an experienced contract manufacturer of medical wire harnesses and cable assemblies.
The company holds multiple certifications to ensure uniform quality of produced medical harnesses and cable assemblies:
- ISO 9001: 2015 (Quality Management)
- ISO 14001: 2015 (Environmental Management)
- ISO 13485: 2016 (Medical Devices Quality Management)
We manufacture all medical wire harnesses in our own 30,000 m² factory and rigorously test every wire to ensure strict compliance with medical industry standards. Contact us to learn more information about our capabilities and to inquire about your project!
